Skip to main content
OpenTrials
Completed

NCT Number: NCT04909593

Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial

The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Back Pain Intractable Pain Low Back Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Back Pain, Intractable Pain, Neuropathic Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PCPMG Clinical Research Unit, LLC

Greenville, South Carolina, 29601, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).
  • Subject signed a valid, EC/IRB-approved informed consent form.
  • Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.
  • In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.

Key Exclusion Criteria:

  • Subject meets any contraindication in BSC neurostimulation system local DFU.
  • Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
  • Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
  • Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.

Treatment and study plan

Spinal Cord Stimulation

Device

Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters

Other names: neurostimulation

Primary outcomes

  1. Perception Threshold

    Time frame: Programming Visit (up to 15 days post-screening)

    Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study

Acronym: AIM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2021
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.